Identifying pathologic complete response of the breast after neoadjuvant systemic therapy with ultrasound guided biopsy to eventually omit surgery: Study design and feasibility of the MICRA trial (Minimally Invasive Complete Response Assessment)
Identifying pathologic complete response of the breast after neoadjuvant systemic therapy with ultrasound guided biopsy to eventually omit surgery: Study design and feasibility of the MICRA trial (Minimally Invasive Complete Response Assessment)
复制标题
DOI：
10.1016/j.breast.2018.04.015
复制
发表时间：
2018-08-01
期刊：
影响因子：
3.9
通讯作者：
Peeters, M. T. F. D. Vrancken
中科院分区：
文献类型：
--
作者：
van der Noordaa, M. E. M.;van Duijnhoven, F. H.;Peeters, M. T. F. D. Vrancken
目的：乳腺癌患者新辅助全身治疗（NST）的改善导致病理完全缓解（pCR）率增加。MICRA试验（NTR 6120）旨在通过NST后活检鉴定pCR。在这里，我们报告的研究设计和可行性。方法：MICRA试验是一个多中心的前瞻性队列研究。NST前放置标记物且NST后MRI显示放射学完全（rCR）或部分缓解的患者有资格入选。对原始肿瘤区域进行超声引导活检。并将活检标本与手术标本的病理结果进行比较。主要终点是假阴性率活检在确定pCR.Results：在第一年的试验58例rCR。1例患者筛选失败，被排除在分析之外。21%患有激素受体（HR）+/HER 2-肿瘤，21% HR+/HER 2+肿瘤，18% HR-/HER 2+肿瘤和40% TN肿瘤。总体pCR为68%。7名患者无法获得活检：6名患者在手术室的超声上无法识别标记物，1名患者存在技术困难。平均8次活检（范围4-9）。结论：对MRI检查结果良好的患者行NST后，超声引导下乳腺活检是可行的。MICRA试验的准确性结果将在纳入525例患者后提供，以确定超声引导活检是否是NST后评估pCR的手术切除的准确替代方法。(c)2018爱思唯尔有限公司版权所有
Purpose: Improvements in neoadjuvant systemic therapy (NST) for breast cancer patients have led to increasing rates of pathologic complete response (pCR). The MICRA trial (NTR6120) aims at identifying pCR with post-NST biopsies. Here, we report the study design and feasibility.Methods: The MICRA-trial is a multi-center prospective cohort study. Patients with a pre-NST placed marker and radiologic complete (rCR) or partial response on MRI after NST are eligible for inclusion. Ultrasound guided biopsy of the original tumor area is performed. Pathology results of the biopsies and surgery specimens are compared. The primary endpoint is false-negative rate of biopsies in identifying pCR.Results: During the first year of the trial 58 patients with rCR were included. One patient was a screening failure and excluded for analysis. Twenty-one percent had hormone receptor (HR)+/HER2- tumors, 21% HR+/HER2+ tumors, 18% HR-/HER2+ tumors and 40% TN tumors. Overall pCR was 68%. In seven patients biopsies could not be obtained: in 6 patients, the marker could not be identified on ultrasound in the OR and in 1 patient there were technical difficulties. A median of eight biopsies was obtained (range 4-9). The median of histopathological representative biopsies was 4 (range 1-8).Conclusion: Ultrasound guided biopsy of the breast in patients with excellent response on MRI after NST is feasible. Accuracy results of the MICRA trial will be presented after inclusion of 525 patients to determine if ultrasound guided biopsy is an accurate alternative to surgical resection for assessment of pCR after NST. (c) 2018 Elsevier Ltd. All rights reserved.